Persona® Trabecular Metal® 42-5450-005-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024560659), received between Feb 17, 2022 and Jul 14, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K181947, K191625); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT IS BEING CONSIDERED FOR A DFR TO ARCOS STEM CONVERSION. THE PATIENT PREVIOUSLY HAD ZSS COMPONENTS IMPLANTED, HOWEVER THE PATIENT¿S BONE QUALITY IS NOT SUFFICIENT FOR CEMENT FIXATION. THE PATIENT ORIGINALLY HAD A ZSS CEMENTED STEM IMPLANTED, IT BECAME LOOSE AND THEN ANOTHER ZSS CEMENTED STEM WAS RE-IMPLANTED, AND NOW THE CURRENT INDWELLING CEMENTED STEM IS ALSO LOOSENING. THE SURGEON IS REQUESTING A CUSTOM ZSS TO ARCOS ADAPTER TO MATE WITH THE CURRENT INDWELLING ZSS FEMUR TO REPLACE THE CURRENT INDWELLING CEMENTED ZSS STEM WITH A SPLINED ARCOS STEM. SURGEON DOES NOT WANT TO REVISE THE WELL-FIXED TIBIAL IMPLANTS AND IS JUST REQUESTING A CUSTOM ZSS TO ARCOS ADAPTER TO MATE WITH THE ZSS FEMORAL COMPONENT AND AN ARCOS STEM. THE TIBIAL CONE FROM THE CURRENT INDWELLING IS IMPLANTED ON THE FEMORAL SIDE THROUGH THE FEMORAL STEM, THEREFORE, THE TIBIAL COMPONENTS ON THE TIBIAL SIDE ARE NOT GOING TO BE REPLACED, BUT THE ONE ON THE FEMORAL SIDE WILL BE REMOVED. IT IS THOUGHT THAT THE SURGEON IMPLANTED IT ON THE FEMORAL SIDE TO TRY AND AID IN GETTING THE STEM TO REMAIN FIXED. THE TARGETED REVISION DATE IS EARLY NOVEMBER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HA

  Patient problems: Aseptic loosening; Pain

  MAUDE report 25813709 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN TWO YEARS AND FOUR MONTHS POST IMPLANTATION. THE TIBIAL, STEM AND TIBIAL CONE IMPLANTS WERE REVISED FOR CAUSE, THE ARTICULAR SURFACE WAS ALSO REPLACED AS BEST PRACTICE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22282173 ↗
• InjuryJun 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE IMPLANTS AND REPORTED PAIN. THE IMPLANTS WERE FOUND TO BE LOOSE BUT WELL-ADHERED TO THE CEMENT MANTLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain

  MAUDE report 19468824 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 11 WEEKS POST IMPLANTATION, THE PATIENT DEVELOPED SWELLING, INFLAMMATION, AND PES BURSITIS OF THE RIGHT KNEE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH A CORTISONE INJECTION AND THE ISSUES RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 13568785 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED MODERATE L PES ANSERINE BURSITIS APPROXIMATELY EIGHT MONTHS POST IMPLANTATION. THE PATIENT WAS GIVEN CORTISONE INJECTIONS AND THE ISSUE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 13548380 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181947, K191625. One submission often covers many models, so check the product and lot details in each record.

• Z-2578-2026 · May 11, 2026 · Open, Classified
  Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: